In this episode, Shannon Heacock, Head of Regulatory Submissions at WAYS Pharmaceutical Services, and Mike Willis, CEO of Tradecraft Clinical Research discuss the planning and production of data submissions.
Shannon brings the regulatory perspective to the conversation while Mike looks at it from the data, programming, and stats view. They cover topics like the most common challenges, risks of noncompliance, and the important role of the Study Data Standardization Plan.

In this episode, Shannon Heacock, Head of Regulatory Submissions at WAYS Pharmaceutical Services, and Mike Willis, CEO of Tradecraft Clinical Research discuss the planning and production of data submissions. Shannon brings the regulatory perspective to the conversation while Mike looks at it from the data, programming, and stats view. They cover topics like the most common challenges, risks of noncompliance, and the important role of the Study Data Standardization Plan.

Data Submissions

Regulatory submission professionals talking about all things regulatory. 
-What's the latest on electronic regulatory submissions?
-What do I need to know about CDISC compliant data packages?
-What are most teams doing to support Ad Promo submissions in eCTD format?
We'll talk about trends, best practices, and emerging regulations. We'll also interview leaders from across the industry to share perspectives and lessons learned. 
Join us!

Business

Regulatory submission professionals talking about all things regulatory. -What's the latest on electronic regulatory submissions? -What do I need to know about CDISC compliant data packages? -What are most teams doing to support Ad Promo submissions in eCTD format? We'll talk about trends, best practices, and emerging regulations. We'll also interview leaders from across the industry to share perspectives and lessons learned. Join us!

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Data Submissions

Data Submissions